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Clinical trial

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves (PARTNER II)

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Last updated:1st Mar 2011

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [Edwards Study 2010-12]
Estimated Enrollment: 5650
Study Start Date: March 2011
Estimated Study Completion Date: September 2020
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
SAPIEN XT™ valve with the NovaFlex or NovaFlex+ delivery syst
- Experimental: SAPIEN XT™ valve with the Ascendra2 and Ascendra+ Delivery Sys
- Active Comparator: SAPIEN® valve with the RetroFlex3™ delivery system
- Active Comparator: AVR with a surgical bioprosthetic heart valve
- Experimental: SAPIEN 3™valve with the Commander Delivery System
- Experimental: SAPIEN 3™ valve with the Certitude Delivery System

Category Value
Study start date 2011-03-01

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